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allergEAZE clear Patch Test Chambers are an allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin. allergEAZE clear Patch Test Chambers are a intended for use by, or under the supervision of, a physician as a patch test diagnostic device used in the testing of individuals suspected of having allergic or irritant contact dermatitis.

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Here's an analysis of the provided text regarding the AllergEAZE™ Clear Patch Test Chambers, focusing on the absence of specific details related to device performance studies and acceptance criteria:

The provided FDA communication letters (K103409) do not contain information about acceptance criteria or a study proving the device meets those criteria, nor do they detail performance metrics, sample sizes, ground truth establishment, or expert involvement for such studies.

These letters primarily concern:

• An administrative change in the device's product code (K103409, a letter from November 1, 2024, updating the code from LDH to KXF).
• The original substantial equivalence (SE) determination (K103409, a letter from March 15, 2011).

The March 15, 2011, letter confirms that the device was found substantially equivalent to predicate devices, meaning it has similar intended use and technological characteristics to a legally marketed device and does not raise different questions of safety and effectiveness. This determination generally implies that the performance of the AllergEAZE™ Clear Patch Test Chambers is considered acceptable based on its similarity to existing, approved devices, rather than through a new, comprehensive performance study explicitly detailed within these documents.

Therefore, I cannot provide the requested information as it is not present in the provided input.

In a typical submission for a device requiring performance data, you would expect to see sections discussing:

1. A table of acceptance criteria and the reported device performance: This would list specific quantitative or qualitative targets (e.g., sensitivity, specificity, accuracy, precision, durability, sterility, biocompatibility) and the results obtained from testing.
2. Sample size and data provenance: Details on the number of samples (patients, test units) used, whether the data was collected prospectively or retrospectively, and origin information.
3. Number and qualifications of experts: For studies involving expert review (e.g., image interpretation), information on the number of experts, their specialty, and experience.
4. Adjudication method: How disagreements among experts were resolved.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: If the device assists human interpretation, this would compare human performance with and without the device.
6. Standalone performance: The performance of the algorithm or device without human intervention.
7. Type of ground truth: How the true status of each case was determined (e.g., biopsy, clinical follow-up, consensus of multiple experts).
8. Training set sample size and ground truth establishment: For AI/ML-driven devices, information about the data used to train the model, and how its ground truth was established.

Conclusion based on the provided documents:

The provided FDA letters for AllergEAZE™ Clear Patch Test Chambers do not contain the details necessary to answer your specific questions regarding acceptance criteria and performance study outcomes. The regulatory action is based on substantial equivalence to a predicate device, which usually means the detailed performance studies (if they were performed for the 510(k)) were not fully articulated in these summary letters, or that the performance was considered "substantially equivalent" rather than requiring new, detailed clinical performance data compared against specific metrics.

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